On November 9, 2023 Inhibrx, Inc. (Nasdaq: INBX), or Inhibrx, or the Company, a biopharmaceutical company with four programs in ongoing clinical trials and a strong emerging pipeline, reported financial results for the third quarter of 2023 and provided an update on recent corporate highlights (Press release, Inhibrx, NOV 9, 2023, View Source [SID1234637373]).
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Recent Corporate Highlights
•On August 29, 2023, Inhibrx announced that it had entered into a securities purchase agreement, or the Purchase Agreement, for a private placement financing, or the PIPE, resulting in gross proceeds of approximately $200.0 million. Pursuant to the Purchase Agreement, the Company sold and issued to certain institutional and other accredited investors, or the Purchasers, 3,621,314 shares of its common stock at a purchase price of $19.35 per share and, with respect to certain Purchasers, pre-funded warrants to purchase 6,714,636 shares of its common stock at a purchase price of $19.3499 per pre-funded warrant, which have an exercise price of $0.0001 per share.
•On September 19, 2023, Inhibrx announced that it had retained full global rights to INBRX-101 as a result of Chiesi Farmaceutici S.p.A declining to exercise its option for the ex-North American rights to develop and commercialize INBRX-101 for the treatment of patients with emphysema due to Alpha-1 Antitrypsin Deficiency, or AATD.
•On November 2, 2023, Inhibrx announced preliminary efficacy and safety data at the Annual Connective Tissue Oncology Society (CTOS) Conference from the Phase 1 trial of INBRX-109 in combination with Irinotecan (IRI) and Temozolomide (TMZ) for the treatment of advanced or metastic, unresectable Ewing sarcoma. Among the 13 patients evaluable as of the data cut of September 8, 2023, the observed disease control rate was 76.9%, or 10 out of 13 patients as measured by RECISTv1.1, with 7 patients achieving partial responses (53.8%) and 3 patients achieving stable disease (23.1%). Durable clinical benefit was observed in 4 patients (30.8%) who achieved disease control lasting greater than 6 months. Overall, INBRX-109 in combination with IRI/TMZ was well tolerated. The most common adverse events were diarrhea, nausea and fatigue, all consistent with the known safety profile of IRI/TMZ.
Financial Results
•Cash and Cash Equivalents. As of September 30, 2023, Inhibrx had cash and cash equivalents of $337.3 million, compared to $192.5 million at June 30, 2023. During the third quarter of 2023, the Company received gross proceeds of $200.0 million from the PIPE. These proceeds were offset in part by cash outflows from operations, which increased during the third quarter of 2023 primarily due to the following activity:
◦a large upfront payment made to one of the Company’s contract development and manufacturing organizations, or CDMOs, for the prepayment of raw materials for future manufacturing runs, as well as other increased development and manufacturing costs to support its clinical candidates; and
◦the Company’s payments to its contract research organizations, or CRO, partners continue to increase as the registration-enabling Phase 2 trials progress for both INBRX-101 for the treatment of emphysema due to AATD and INBRX-109 for the treatment of unresectable or metastatic conventional chondrosarcoma, and additional cash outlay to its CRO partners for the INBRX-105 and INBRX-106 Phase 1/2 trials.
•R&D Expense. Research and development expenses were $38.1 million during the third quarter of 2023, compared to $24.9 million during the third quarter of 2022. The increase in research and development expenses was primarily due to the following factors:
◦an increase in clinical trial expenses, primarily related to the registration-enabling Phase 2 trial for INBRX-101 for the treatment of emphysema due to AATD, which was initiated during the current year, as well as the progression of its INBRX-109 registration-enabling Phase 2 trial for the treatment of unresectable or metastatic conventional chondrosarcoma;
◦an increase in CMC expenses due to the nature of the development and manufacturing activities performed at its CDMO and CRO partners supporting the Company’s clinical and preclinical therapeutic candidates, which reflect the stage-specific needs of its programs during each period, including early and late stage drug substance clinical manufacturing, drug product manufacturing, and selected biologics license applications-enabling activities; and
◦an increase in personnel-related costs, partially attributable to an increase in headcount as the Company continues to expand its clinical teams, as well as the issuance of additional stock options and the expansion of the Company’s bonus eligibility pool in the current year.
•G&A Expense. General and administrative expenses were $7.9 million during the third quarter of 2023, compared to $5.3 million during the third quarter of 2022. The increase in general and administrative expenses was primarily due to the following factors:
◦an increase in additional personnel-related costs in part due to the expansion of the Company’s commercial strategy and medical affairs team as well as the issuance of additional stock options and the expansion of its bonus eligibility pool in the current year;
◦an increase in consulting services supporting the Company’s commercial operations business intelligence strategies, as well as market research and other scientific publication expenses incurred related to the Company’s continued pre-commercialization efforts for INBRX-101 and INBRX-109; and
◦an increase in professional service expenses related to accounting and legal services which support the Company in its general corporate and intellectual property matters.
•Net Loss. Net loss was $51.8 million during the third quarter of 2023, or $1.10 per share, compared to $35.3 million during the third quarter of 2022, or $0.90 per share.